510(k) · Cleared
Recalled · Class II · 2019Bio-Modular Shoulder System with Hydroxyapatite (HA) Coated Glenoid Components
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Biomet, Inc. · MBF Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer, Uncemented
Cleared on Feb 17, 2005 as substantially equivalent to K030710 (Biomet, Inc., 2003) after a 100-day review. Its family tree reaches back 4 generations to 1980. 1 of the 192 devices in its family, counting itself, has a Class I recall. 176 later devices descend from it. It has been recalled once.
- Decided
- Feb 17, 2005
- Review
- 100 days
- Class
- Class II
- Product code
- MBF
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 4 generations to K800494 (1980). 15 ancestors in all. 176 later devices descend from it, 1 citing it directly. 1 of the 192 devices in this family, counting this one, has a Class I recall.
- Root · 4 generations backK800494 New Jersey Hemiarthroplasty Sholder ProsDepuy, Inc. · 1980
- 3 generations backK991585 Bipolar Shoulder ProsthesisBiomet, Inc. · 1999
- 2 generations backK002998 Biomet BI-Polar Shoulder SystemBiomet, Inc. · 2000 · Recalled
- 1 generation backK030710 Bio-Modular Shoulder SystemBiomet, Inc. · 2003 · Recalled
- This deviceK043100 Bio-Modular Shoulder System with Hydroxyapatite (HA) Coated Glenoid…Biomet, Inc. · 2005
- Descendant · cites it directly · 175 of its ownK072804 Comprehensive RS Shoulder SystemBiomet Manufacturing Corp · 2007
- Descendant · 2 generations on · 172 of its ownK080642 Comprehensive Reverse ShoulderBiomet, Inc. · 2008 · Recalled (Class I)
- Descendant · 3 generations on · 108 of its ownK110599 Aequalis Ascend Modular Reverse Shoulder SystemTornier, Inc. · 2011
- Descendant · 4 generations on · 97 of its ownK112615 Aequalis Ascend Modular Reverse Shoulder SystemTornier, Inc. · 2011
- Descendant · 5 generations on · 96 of its ownK122698 Aequalis Ascend Flex Shoulder SystemTornier S.A.S. · 2013 · Recalled
Showing 5 of 176 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K080642 Comprehensive Reverse Shoulder2 generations on · 2008
Most influential descendants
Showing 5 of 176 · See all- K072804Comprehensive RS Shoulder SystemBiomet Manufacturing Corp · 2007 · cites it directly175descendants
- K080642Comprehensive Reverse ShoulderBiomet, Inc. · 2008 · 2 generations on172descendants
- K110599Aequalis Ascend Modular Reverse Shoulder SystemTornier, Inc. · 2011 · 3 generations on108descendants
- K112615Aequalis Ascend Modular Reverse Shoulder SystemTornier, Inc. · 2011 · 4 generations on97descendants
- K122698Aequalis Ascend Flex Shoulder SystemTornier S.A.S. · 2013 · 5 generations on96descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K800494 | New Jersey Hemiarthroplasty Sholder Pros | Depuy, Inc. | 1980 | — |
| −3 | K991585 | Bipolar Shoulder Prosthesis | Biomet, Inc. | 1999 | — |
| −2 | K002998 | Biomet BI-Polar Shoulder System | Biomet, Inc. | 2000 | 1 |
| −1 | K030710 | Bio-Modular Shoulder System | Biomet, Inc. | 2003 | 1 |
| 0 (this device) | K043100 | Bio-Modular Shoulder System with Hydroxyapatite (HA) Coated Glenoid Components | Biomet, Inc. | 2005 | — |
| +1 | K072804 | Comprehensive RS Shoulder System | Biomet Manufacturing Corp | 2007 | — |
| +2 | K080642 | Comprehensive Reverse Shoulder | Biomet, Inc. | 2008 | Class I |
| +3 | K110599 | Aequalis Ascend Modular Reverse Shoulder System | Tornier, Inc. | 2011 | — |
| +4 | K112615 | Aequalis Ascend Modular Reverse Shoulder System | Tornier, Inc. | 2011 | — |
| +5 | K122698 | Aequalis Ascend Flex Shoulder System | Tornier S.A.S. | 2013 | 2 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1980 | 1 | 0 |
| 1987 | 1 | 0 |
| 1992 | 2 | 0 |
| 1994 | 1 | 0 |
| 1995 | 1 | 0 |
| 1998 | 2 | 0 |
| 1999 | 2 | 0 |
| 2001 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 1 | 0 |
| 2008 | 1 | 1 |
| 2010 | 3 | 0 |
| 2011 | 3 | 0 |
| 2012 | 5 | 0 |
| 2013 | 8 | 0 |
| 2014 | 6 | 0 |
| 2015 | 3 | 0 |
| 2016 | 4 | 0 |
| 2017 | 10 | 0 |
| 2018 | 9 | 0 |
| 2019 | 13 | 0 |
| 2020 | 14 | 0 |
| 2021 | 21 | 0 |
| 2022 | 16 | 0 |
| 2023 | 13 | 0 |
| 2024 | 13 | 0 |
| 2025 | 15 | 0 |
| 2026 | 18 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
1 device in this family has a Class I recall. A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new MBF device
- #1 K202716 Ignite Anatomic Shoulder Systemscore 20.3 · 14 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K030710 | Bio-Modular Shoulder SystemSummary page 1…21 CFR § 888.3690 Legally Marketed Devices To Which Substantial Equivalence Is Claimed: Bio-Modular® Shoulder System (K030710) - Biomet Inc. Device Description: The Rio-Modular® Shoulder System is a set of components intended for total or… | 2003 |
What descends from it? (176)
See all 1761 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K072804 | Comprehensive RS Shoulder System | 2007 | 175 |
Has anything in its family been recalled? (1 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Aug 21, 2019 | Class II | Z-0533-2020 | Environmental control | Elevated levels of bacterial endotoxin and residual debris remain on the devices due to cleaning issue. |
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K080642Comprehensive Reverse ShoulderBiomet, Inc. · 2008 · 2 generations on · ◆ in the 2008 descendants bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 25 years and passes through 2 companies; a new generation was cleared every 2.7 years on median.
- 3 of the 15 ancestors have a recall of any class.
- Of its descendants, K072804 (Biomet Manufacturing Corp, 2007) has gone furthest, with 175 descendants of its own.
- 19 other devices also cite its predicate K030710.
How does its category compare?
All MBF devicesMBF Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer, Uncemented: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · MBF
2in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · MBF
144in 2023
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MBF
1in 2023
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MBF
255in 2025
MAUDE reports naming product code MBF, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 2 | — | 0 | 2 |
| 2008 | 1 | — | 0 | 7 |
| 2009 | 1 | — | 1 | 16 |
| 2010 | 0 | — | 0 | 24 |
| 2011 | 0 | — | 0 | 32 |
| 2012 | 2 | — | 0 | 30 |
| 2013 | 1 | — | 0 | 40 |
| 2014 | 1 | — | 0 | 28 |
| 2015 | 0 | — | 0 | 49 |
| 2016 | 0 | — | 0 | 85 |
| 2017 | 2 | — | 1 | 193 |
| 2018 | 1 | — | 1 | 99 |
| 2019 | 2 | — | 2 | 47 |
| 2020 | 2 | — | 0 | 24 |
| 2021 | 1 | — | 0 | 36 |
| 2022 | 4 | 164 | 8 | 114 |
| 2023 | 4 | 144 | 1 | 143 |
| 2024 | 2 | — | 0 | 164 |
| 2025 | 2 | — | 0 | 255 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis, Rheumatoid arthritis, Revision where other devices or treatments have failed, Correction of functional deformity, Fractures of the proximal humerus, where other methods of treatment are deemed inadequate, Difficult clinical management problems, including cuff arthropathy, where other methods of treatment may not be suitable or may be inadequate. Humeral…
Read the full statement (195 words)
Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis,
Rheumatoid arthritis,
Revision where other devices or treatments have failed,
Correction of functional deformity,
Fractures of the proximal humerus, where other methods of treatment are deemed inadequate,
Difficult clinical management problems, including cuff arthropathy, where other methods of treatment may not be suitable or may be inadequate.
Humeral components with a Macrobond surface coating are indicated for either cemented or uncemented press-fit applications.
Humeral/glenoid components with a porous coated surface coating are indicated for either cemented or uncemented biological fixation applications (Metal backed glenoid components offer optional screw fixation).
Glenoid components with Hydroxyapatite (HA) coating applied over the porous coating are indicated only for uncemented biological fixation applications (Metal backed glenoid components offer optional screw fixation).
Humeral components with a non-coated (Interlok) surface are indicated for cemented application only.
Polyethylene glenoid components not attached to a metal back are indicated for cemented application only.
The Comprehensive Humeral Fracture Stem is intended for use with the Bio-Modular humeral heads and glenoid components.
The Versa-Dial Humeral Head Prosthesis is intended for use only with the Comprehensive Humeral Fracture Stem and the glenoid components of the Bio-Modular Shoulder System.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K043100 · printed Nov 6, 2026
Cite this page
510(k) Report. “K043100: Bio-Modular Shoulder System with Hydroxyapatite (HA) Coated Glenoid Components.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K043100
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026